NCT03131375

Dexmedetomidine Reduces Emergence Delirium in Children Undergoing Tonsillectomy With Propofol Anesthesia

Dexmedetomidine Reduces Emergence Delirium in Children Undergoing Tonsillectomy With Propofol Anesthesia: a Prospective, Randomized, Double-blind, Single-center Study.

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Athens General Children's Hospital "Pan. & Aglaia Kyriakou" · Academic / Other
• Sex: All
• Age: 3 Years – 14 Years
• Healthy volunteers: Not accepted

Summary

Dexmedetomidine (DEX) is safe and effective in reducing ED following sevoflurane anesthesia. The investigators intend to study the efficacy of DEX in reducing ED in children undergoing tonsillectomy with and without adenoidectomy using total intravenous anesthesia (TIVA) with propofol .

Conditions

• Emergence Delirium
• Extubation Time
• Heart Rate
• Postoperative Analgesia
• Blood Pressure

Interventions

Type	Name	Description
DRUG	Dexmedetomidine	Group A and B: Anesthesia induction drugs:propofol, fentanyl, rocuronium . After induction of anesthesia: Group A receives a 50 ml NS infusion containing 1 mcg kg-1 Dexmedetomidine drug Group A and B: Atropine as an antisialagogue, dexamethasone, ondasetrone for the prevention of postoperative nausea and vomiting. Anesthesia maintainance: propofol, remifentanil and oxygen in air. End of surgery, the infusion of propofol and remifentanil stop and sugammadex for reversal of neuromuscular block is given. Postoperative analgesia by nalbuphine 0.2 mg kg-1 given before the end of surgery in Group B, and 0.16 mg kg-1 in Group A. Monitoring: ECG, NIBP, ETCO2, SpO2, Bispectral index , Train of four ratio.
DRUG	Normal saline	Group A and B: Anesthesia induction drugs:propofol, fentanyl, rocuronium . After induction of anesthesia: Group B receives a volume matched Normal saline infusion. Group A and B: Atropine as an antisialagogue, dexamethasone, ondasetrone for the prevention of postoperative nausea and vomiting. Anesthesia maintainance: propofol, remifentanil and oxygen in air. End of surgery, the infusion of propofol and remifentanil stop and sugammadex for reversal of neuromuscular block is given. Postoperative analgesia by nalbuphine 0.2 mg kg-1 given before the end of surgery in Group B. Monitoring: ECG, NIBP, ETCO2, SpO2, Bispectral index, Train of four ratio.
DEVICE	Bispectral index	Group A and B: Monitoring depth of anesthesia by BIS device and adjusting propofol infusion according to measurements, aiming to BIS values: 40-60
DEVICE	Train of four ratio	Group A and B: Monitoring recovery of neuromuscular function with TOF-Watch device, to ensure TOFR equals or greater than 90% at the end of the procedure

Timeline

• Start date: 2017-05-01
• Primary completion: 2017-07-30
• Completion: 2017-07-30
• First posted: 2017-04-27
• Last updated: 2018-07-09

Locations

1 site across 1 country: Greece